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Monday, September 11, 2017

There were three brave soles willing to try IHE-MHD Profile here at the FHIR Connectathon.

Diego Kaminker (ALMADOC project / Argentina)

Fernando Campos (ALMADOC project / Argentina)

Simon Knee (NHS Digital / UK)

They did all the hard work. I just answered questions and such...

They had a specific goal: They wanted to test the IHE-MHD Profile against general purpose FHIR Servers. Specifically FHIR Servers that have not declared IHE-MHD Profile, but which do declare support for the fundamentals that IHE-MHD needs. This task is important as it is a way of testing how well I did at writing the IHE-MHD profile. How well did I stick close to FHIR (STU3), and how well did I inform the audience of the deviations.

I tried really hard to write IHE-MHD in away that a general purpose FHIR Server would work. However this was not the intended scope for IHE-MHD. The intended scope or IHE-MHD was as an API to an XDS, XDR, or XCA environment. Thus when I wrote IHE-MHD, I did have to constrain it in ways that a general purpose FHIR Server might not support.

This said, there was some big surprises.

I will summarize the reportout, It is available, with the actual XML examples and evidence.

Results

1 - During a ITI-65 "Provide Document Bundle", that carries both a Binary and a DocumentReference that points at that Binary, MHD expects that the DocumentReference.content.attachment.url would be "fixed up" by the server. That is when the server persists the Binary, and thus fixes up the Binary id from a URI (GUID) to a URL on the server, that new URL would be placed into the DocumentReference.content.attachment.url, which previously held the same URI (GUID) from the Bundle. This behavior does work when the FHIR Reference datatype is used, and did work in prior versions of FHIR (Prior to the Reference becoming a complex datatype vs just a flavor of URL), and the example in the FHIR specification shows this fixup behavior.

Recommend that in a Transaction, that URL fixup is done just like it is with Reference.

some zulip chat recommended that DocumentReference.content.attachment.data be used, but there are many problems with that. Most of all that it is very counter to the IHE XD* use-case need.

If this isn't resolvable, then the next revision of MHD might need to define ITI-65 as a FHIR Operation, rather than using the Transaction. I don't think this should be done until FHIR STU4. But I would entertain someone wanting to define this as an option. However I would remind everyone that IHE-MHD is not trying to use general purpose FHIR Servers, it is as an API to XD*.

One cold just do two transactions. One to create the Binary, then create the DocumentReference with a client fixedup URL. This can be done with general purpose FHIR Servers, but would be counter to the target for IHE-MHD being an API to XD*.

I will write a CP to MHD to make this more clear as an MHD imposed requirement of MHD servers.

2 - Already known issue #MHD_048 -- This was not a new issue, since we knew of it. But this issue was not obvious in the MHD text, so it caused issues. The default behavior for a general purpose FHIR Server is that one can't search against "contained" resources. In IHE-MHD we just left this as an open issue, we didn't try to solve it completely.

The bad news is that one can't tell if this will work from a servers conformance resource.

I will write a CP that uses this feature that I didn't notice.

3 - Search on Patient.identifier -- An issue I simply didn't expose as much as I could have. This is a chained search, and will only work when the server you are querying against also hosts the Patient resources. For example: Imagine a FHIR Server that holds all of the DocumentReferences (the MHD server), and a different FHIR Server that holds the Patient resources (likely available via PDQm or PIXm). You can do a PIXm or PDQm query against this second server, and use the resulting URL in your MHD queries against the first server. This is just URL matching. But if you try to query the MHD server using Patient.identifier, that server will not know how to find the Patient.identifier.

This might be an important problem, or might not. It depends on deployment needs and capabilities.

I will likely write a CP to make this more clear in MHD

Conclusion

Overall this was really cool to do this kind of testing of the MHD specification. Especially since it resulted in some CR to FHIR, and likely a CP to IHE.

Friday, September 8, 2017

I have been working with some of the teams wanting to do something with Privacy Consent and are coming to the FHIR Connectathon in San Diego. Here is a few stepping stones that I think are educational to move from zero to a reasonable set of Consent possibilities. Basic Consent is a necessary and powerful step:

Pre-conditions:

Some form of Business Access Control are already in place to support basics of separating the kinds of things that various users (roles) are allowed to do; like Clinicians, or administrative staff, or billing staff, or cleaning staff, or dietary staff, etc. For example: Role Based Access Control (RBAC), or Attribute Based Access Control (ABAC) . This layer is responsible for separating those users that are allowed to Order drugs or procedures, vs those that are allowed to update clinical information, vs those that are given access to billing information, vs etc... An example of this is -- SMART-on-FHIR.

There is some Privacy Policy written: I will give a few for example purposes only. These are not complete, or comprehensive. They are defined well enough to illuminate the various stepping stones that I will outline below.* Explicit Consent -- if no consent is on file, then no data is shared outside the organization.* OPT-IN -- Patient has positively given consent to share without restrictions* OPT-IN with named organizations allowed access* OPT-IN with identified time/date range within which no data authored can be sharedSo, any Consent in the system must be from one of these patterns. Mixing of patterns, or going beyond these patterns is simply not allowed by the consent gathering application.**** Sorry, I have to use "OPT-IN" and "OPT-OUT", against my rule... but I do have them explained.

There is some consent gathering application that presents these Privacy Policies to Patients, and records the Consent ceremony as a FHIR Consent resource. I am not going to try to describe this ceremony. The user experience is very critical. The Patient must be well educated on the ramifications of their choices. I like the idea in GDPR where the consent rules presented to the Individual must be in human language terms that are specific to that person's language abilities. I am not short-circuiting this, but rather wanting to focus on the enforcement side.*** Note that if the patient changes their mind, this application handles this. Leaving only ONE active Consent resource. Thus there is no conflicts to resolve in real-time. If the patient wants to OPT-OUT after being OPT-IN; then a few solutions could happen. The existing record be updated to become Consent.status=rejected. Better for record keeping if a new Consent record is created with an OPT-OUT policy...

YES, I know that we all want more complex consents, we will get there. But for now we must get started. Stepping stones are important to the journey. Stepping stones are useful, but one does not stand on them for very long.

Consent Enforcement Models

There are two major models today, very different.

Privacy Access Control decision engine

Privacy Access Control decision engine using OAuth. In this model, one offloads the Access Control decision to an OAuth authorization service. This is the model that HEART is focused on. Another example has been shown as "Cascading OAuth". The idea is that there is some OAuth authority (or a set of them) that focus on giving Access Control decisions purely along Privacy Consent lines. If this is 'cascaded' with the business OAuth Access Control decisions; then one has the combination of both.. I am not going to further explain this model in this blog article.

One could have an Access Control engine that is based on XACML...

In both of these solutions, the rules of the Patient specific Consent are not in any FHIR 'Consent' resource form. These solutions take care of steps 1-4. They only expose a 'decision' endpoint.

As such, their decision endpoint must be able to return complex obligations. PERMIT, but not to organization ABC, not the data authored during XYZ, etc... These in OAuth would be done with "Scopes", in XACML would be done with 'Obligations'. Which ever one uses, this is complex... and I would argue this is the same complexity one sees in the FHIR Consent resource today.

In both of these solutions, there might be a FHIR Consent that is simply there to indicate the endpoint of the Privacy Access Control service. This might be quite empowering. The Consent would not indicate anything other than the specific service to use. Thus enabling the Patient to choose from various Privacy Access Control services to use. The FHIR Consent resource would not indicate in any way what their Privacy rules might be.

I should model this.. and I might do it this week... but I want to focus on a solution that leverages the Consent resource... and this Privacy Access Control decision service solution hardly uses the Consent resource at all.

The FHIR Consent way:

Reminder we are working on Stepping Stones, and starting simple* Explicit Consent -- if no consent is on file, then no data is shared outside the organization.* OPT-IN -- Patient has positively given consent to share without restrictions* OPT-IN with named organizations allowed access* OPT-IN with identified time/date range within which no data authored can be shared

Lets first just work out the first two: No active consent on file, vs opt-in.

A system can using FHIR query (RESTful) to determine if there is any Consent on file for a given patient. For the example below we look for if there is a OPT-IN consent for patient 'f001'

GET [base]/Consent?patient=f001&status=active&category=http://hl7.org/fhir/v3/ActCode#OPTIN(((Note that one can't query on policyRule, so I propose either that be added, or that the OPTIN code goes into category. I seem to recall committee discussions that put it into category)))

If this above query returns ZERO result, then there is no OPTIN consent on file. Thus no access is granted. DONEIf there is a Consent, then we need to look to see if there are any Consent.provisions. If there are none, then we grant Privacy PERMIT access. DONE

The second stepping stone is to enforce the provisions.

Each provision will have a provision.type of either PERMIT or DENY. This means that if the constraints in the provision are matched, then the provision.type (PERMIT vs DENY) is to be enforced.

We have an example which is an OPTIN but denying access to a named organization.

Well, looking at this example, I see it is missing some critical parts that I just said would be there. The one provision this example has in it is that it is specific to an Organization named 'f001'. From the name of the example, it is clear this provision should have a .type="deny".

This kind of a provision can be enforced on the REQUEST, as that organisation is denied any access because of a Privacy Consent directive.

Date Range:

The Date Range provision is something that is much harder to enforce, as it really must look at the results that are about to be returned, and filter out any data that was authored within the given date range. I am not going to go deeper right now, but am pointing out that sometimes provisions can be enforced on the REQUEST side, denying a request or allowing a request with no further action. Some provisions require further work be done on the RESPONSE side.

It is being revised again, and there is a call for participation. Hurry, there is only a week to signup -- September 8th deadline.

This is intended to be a Security Disclosure statement from a Medical Device (any health software too) to someone purchasing. It is intended to explain the security capability, environmental expectations, and residual risk that would need to be managed by the purchasing organization. Security is a critical collaboration between the manufacture and the user of any system. This form is intended to enable this collaboration.

The Medical Imaging & Technology Alliance (MITA) is announcing an effort to revise the existing HIMSS/NEMA Standard HN1-2013 and develop it as an American National Standard. This standard consists of the Manufacturer Disclosure Statement for Medical Device Security (MDS2) form and related instructions how to complete the form. The intent of the MDS2 form is to supply healthcare providers with important information to assist them in assessing the vulnerability and risks associated with protecting private data transmitted or maintained by medical devices and systems.

If you are interested in participating in the development of this standard, please fill out the information requested below and return to Peter Weems (pweems@medicalimaging.org) no later than August 31, 2017 September 8, 2017.

Name

Organization Represented

Brief Description of Organization

Email Address

Telephone Number

Interest Category

Interest Category Descriptions

General Interest—Organization or individual that has an interest in the use of equipment included in the scope of this Standard, but neither produces nor uses it directly.

Government—Government agency or department that has an interest in the use of equipment included in the scope of this Standard. Please note that a government agency or department that uses this equipment should select the USER category.

Insurance--Insurance agency or department that has an interest in the use of equipment included in the scope of this Standard. Please note that an insurance agency or department that uses this equipment should select the USER category.

Producer—Manufacturer of equipment included in the scope of this Standard.

Testing Laboratory—Organization that tests equipment included in the scope of this Standard to established specifications.

Trade Association—Trade Association or society that represents the interests of manufacturers or users of equipment included in the scope of this Standard.

User—Organization (company, association, government agency, individual) that uses equipment included in the scope of this Standard.

User-consumer—Where the standards activity in question deals with a consumer product, such as lawn mowers or aerosol sprays, an appropriate consumer participant’s view is considered to be synonymous with that of the individual user – a person using goods and services rather than producing or selling them.

User-industrial—Where the standards activity in question deals with an industrial product, such as steel or insulation used in transformers, an appropriate user participant is the industrial user of the product.

User-government—Where the standards activity in question is likely to result in a standard that may become the basis for government agency procurement, an appropriate user participant is the representative of that government agency.

User-labor—Where the standards activity in question deals with subjects of special interest to the American worker, such as products used in the workplace, an appropriate user participant is a representative of labor.

Thursday, August 31, 2017

I finally got caught... I have been elected co-chair of the IHE IT Infrastructure - Planning Committee.

I have been 'co-chair from behind' for too long, I knew I would eventually get caught. I tried to be elected co-chair in IHE once before, but had a campaign against me... by my peers at my employer at the time (GE Healthcare)...

First test will be the face-to-face meeting for New Work Item proposals October 16-17....

YOU have submitted your new work item proposal, right? Better hurry, the deadline is just 22 days away.

This is a friendly reminder that the IHE annual planning cycle has begun! The IT Infrastructure (ITI) and Patient Care Coordination (PCC) Domains are soliciting work item proposals for the 2017 Publication Cycle. The Call for Proposals concludes September 22, 2017.This e-mail provides a brief overview the Call for Proposal process. For detailed information visit the IHE Call for Proposals Wiki site. Are you new to the IHE International Call for Proposal Process?·Watch the online webinar to learn more about submitting a proposal and the evaluation process.Ready to participate in the Call for Proposals?Interested parties are invited to submit a brief proposal (form attached) for new IHE Profiles and/or White Papers to be considered for development in the new Publication Cycle. Proposals should be entered using the attached Brief Profile Proposal template. They should address the following:

What is the problem and how does it look in practice? (Describe the use case)

How should things look in practice if it were fixed?

What specific standards could be used to solve the problem, if known?

If possible, give some indication of the business case for solving the problem (e.g., quantify the cost).

It is strongly recommended that the proposal include the name of an editor for the proposal should it be selected for development.Email your completed brief IHE Proposal template to the corresponding email address listed below before September 22, 2017 at 11:59pm CDT. Proposal templates can also be found online at: ftp://ftp.ihe.net/DocumentPublication/DocumentTemplates/Profile%20Proposal-Brief%20and%20Detailed/IHE_Profile_Proposal_Template-Brief.docx·ITI Domain Proposals: Daniel Berezeanu at: daniel.b...@readycomputing.com, ITI Planning Chair·PCC Domain Proposals: Amit Popat at: Am...@epic.com, PCC Planning ChairWhat happens if my proposal is selected?The IHE ITI and PCC Planning Committee will review each Brief Proposal and select a "short list" of proposals for further consideration. Detailed Profile Proposals are sent to the IHE ITI or PCC Technical Committee for evaluation and returned to the Planning Committee for a final vote. Please visit the Wiki for detailed information about the IHE Call for Proposals. Questions or Comments?

Tuesday, August 29, 2017

Integrating the Healthcare Enterprise (IHE) has been busy creating Profiles that leverage the new and exciting FHIR specification. The concept of Profiling in IHE has been around for just about 20 years. The concept of Profiling is not IHE invention, I first encountered it back in the 1980s with the original set of Internet Protocols. See the IHE FAQ for some nice description of what/who IHE is.

An IHE Profile is equivalent to a FHIR Implementation Guide. They take a specific use-case, define Actors, define Transactions, and define Options; From this a set of interoperability constraints are defined for each Actor within that Profile.

These constraints can be coded as a FHIR set of conformance resources. For now, if a FHIR Conformance resource is available it will be published on the IHE FTP site in the Implementation Material. There are efforts within IHE to modernize beyond an FTP site, and to provide more complete FHIR conformance publication on a FHIR Profile Registry.

IT Infrastructure (ITI) domain

Mobile access to Health Documents (MHD) a profile on DocumentReference and DocumentManifest to provide a HTTP REST and Mobile application friendly API for the usecases profiled in XDS, XDR, and XCA. The MHD profile may be used as an API to these Document Sharing infrastructures, or may be used alone.

Quality, Research, and Public Health (QRPH) domain

Vital Records Death Reporting (VRDR) defines a Retrieve Form for Data Capture (RFD) content profile that will specify derivation of source content from a medical summary document. by defining requirements for form filler content and form manager handling of the content

Pharmacy

The Pharmacy group is working toward a Profile, but it is not yet fully developed.

I am very pleased with my chapter in the book, 32 pages: "Interoperability Within and Across Healthcare Systems". I cover quite a bit of ground on Privacy and Security related to EHR and HIE. Much of the material comes from my blog, but even that had to be rewritten to fit the editorial style of a book. The chapter covers everything from identity, identity proofing, access control, authentication, and role based access control. I cover the various perspectives one must take in healthcare to protect data appropriately; including the patient perspective, provider perspective, and organizational perspective. I cover this topic as an exercise in a local EHR, but also how this model needs to be extended across an HIE to continue to protect the sensitive healthcare information. This requires the expansion out into Metadata and Federated Identity.

Gila also has chapter on Risk Assessment and Management. She didn't have as smooth of an editorial experience as I did.

I expect an update in a year to add chapters on FHIR. There is a very small mention of FHIR in this book, as it was written back during DSTU2. Excitement around FHIR, but not much was clear; and FHIR is not yet the topic in the exams.

Friday, August 25, 2017

My point for that post was that it is important to have a agreed subset of the full character encoding allowed by the e-mail address specification. This subset helps to enable Interoperability, by having everyone make sure that they can send-to, and receive-from, an address fully encoded. This problem came up when some systems had trouble with the apostrophe, such as is needed (desired) for people names like "Fred O’Donnell". That is, a sending HISP didn't allow the user to send to a valid email address because it contained an apostrophe.

The subset of characters I give in E-mail addresses -- Remedial and realistic, is a first line of defense. As the email standard allows a very nasty set of characters, especially if one just puts double-quote around the malicious string. So, I start with the sub-set I defined in the above article.

Unfortunately apostrophe is within that sub-set...

Security Considerations

So as helpful as apostrophe is for people names like "Fred O’Donnell", it is problematic as it can be used in malicious ways. This because the apostrophe is the single-quote. Here are some general email address attack articles:

Direct Threat Analysis

There is a Threat Model within the Direct Project. I lead the sub-group that wrote this Threat Model. The email address as a vector of attack is a situation where you are a Recipient, and the sender is malicious. The sender is trying to tell you that the sender email address is X, where that email address has malicious content.

The good news for Direct Project, is that the sender (you are the recipient) must have signed the email from certificates chaining to YOUR trust store. Thus for this to work, you must be trusting someone who is being malicious. As long as you carefully process up to signature validation, this eliminates the greater Internet attackers.

Thus from the Treat Model, we are most worried about Arch 8, 9, and 10.

It still leaves a Trusted partner as the attacker, but they will get away with this only once before they are found-out and their trust revoked. Thus it better be really valuable attack for them to be motivated to try. So, the likelihood that they would try is very low.

Conclusion

Thus the use of apostrophe (single-quote) does add more risk, over the remedial set, that risk is low because of some mitigating factors (S/MIME, and Trust-Store).

However it is important to have a constrained email address character set, that everyone can FIRST check incoming (or outgoing) addresses against. This because it is far more simple to do simple string validation, before one starts to do operations on that string. Thus a simple string validation would reject a malicious inbound email, and there would be no opportunity to go deeper.

About Me

The information posted here are mine and not necessarily represent By Light Professional IT Services Inc. I am a Standards Architect specializing in Standards Architecture in Interoperability, Security, and Privacy for By Light Professional IT Services Inc. Primarily involved in the international standards development and the promulgation of those standards. Co-chair of the HL7 Security workgroup, a member of the FHIR Management Group, FHIR core team, and co-chair of IHE IT Infrastructure Planning Committee. Participate in ASTM, DICOM, HL7, IHE, ISO/TC-215, Kantara, W3C, IETF, OASIS-Open, and other. Was a core member of the Direct Project specification writing, authoring the security section, and supporting risk assessment. Active in many regional initiatives such as the S&I Framework, SMART, HEART, CommonWell, Carequality, Sequoia (NwHIN-Exchange), and WISHIN. Active in the Healthcare standardization since 1999, during which time authored various standards, profiles, and white papers.

Surely there are other copyright and trademarks that I should recognize, but everyone else seems to be reasonable; expecting readers of blogs know that I am not trying to claim or take ownership of their copyright and trademarks.